This Phase III trial four treatment strategies non-critically ill hospitalized participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin.
This Phase III trial will utilize four treatment strategies in non-critically ill
hospitalized participants (not requiring mechanical ventilation) with SARS CoV-2 infection,
Participants will receive hydroxychloroquine or chloroquine with or without azithromycin.
Investigators are primarily interested in the time to recovery. In addition to study
medications there will be daily symptom surveys for 14 days, then weekly thereafter for 4
weeks resulting in a total duration of follow up of 42 days. During hospitalization, daily
symptom surveys will be completed in conjunction withthe study coordinators. On discharge
participants will have the option to complete electronic symptom surveys or complete symptom
surveys via telephone with study coordinator. In the event that the participant opts for
electronic symptom surveys on discharge participants will in addition receive a follow up
call from a study coordination every 7 days during the initial 14 day period. In addition,
failure to submit a symptom survey will prompt a study follow up call. Data from SOC will be
collected from medical records.
Drug: Hydroxychloroquine Sulfate
anti-rheumatic drug (DMARD)
Other Name: HYDROXYCHLOROQUINE Plaquenil
Drug: Azithromycin
Antibiotic
Other Name: COMMON BRAND(S): Zithromax GENERIC NAME(S): Azithromycin
Drug: Chloroquine Sulfate
Antimalarial
Other Name: Aralen GENERIC NAME(S): Chloroquine Phosphate
Inclusion Criteria:
- Hospitalization for management of SARS CoV-2 infection
- Positive SARS CoV-2 test
- Age >=18 years
- Provision of informed consent
- Electrocardiogram (ECG) ≤48 hours prior to enrollment
- Complete blood count, glucose-6 phosphate-dehydrogenase (G6PD), comprehensive
metabolic panel and magnesium ≤48 hours prior to enrollment from standard of care.
- If participating in sexual activity that could lead to pregnancy, individuals of
reproductive potential who can become pregnant must agree to use contraception
throughout the study. At least one of the following must be used throughout the study:
- Condom (male or female) with or without spermicide
- Diaphragm or cervical cap with spermicide
- Intrauterine device (IUD)
- Hormone-based contraceptive
Exclusion Criteria:
- Contraindication or allergy to chloroquine, hydroxychloroquine or azithromycin
- Current use hydroxychloroquine, chloroquine or azithromycin
- Concurrent use of another investigational agent
- Invasive mechanical ventilation
- Participants who have any severe and/or uncontrolled medical conditions such as:
- unstable angina pectoris,
- symptomatic congestive heart failure,
- myocardial infarction,
- cardiac arrhythmias or know prolonged QTc >470 males, >480 female on ECG
- pulmonary insufficiency,
- epilepsy (interaction with chloroquine),
- Prior retinal eye disease
- Concurrent malignancy requiring chemotherapy
- Known Chronic Kidney disease, eGFR<10 or dialysis
- G-6-PD deficiency, if unknown requires G6PD testing prior to enrollment
- Known Porphyria
- Known myasthenia gravis
- Currently pregnant or planning on getting pregnant while on study
- Breast feeding
- AST/ALT >five times the upper limit of normal ULN*
- Bilirubin >five times the ULN*
- Magnesium <1.4 mEq/L*
- Calcium <8.4mg/dL >10.6mg/dL*
- Potassium <3.3 >5.5 mEg/L*
Washington University School of Medicine Infectious Disease Clinical Research Unit
Saint Louis, Missouri, United States
Washington University School of Medicine
Saint Louis, Missouri, United States
Jane O'Halloran, MD PhD, Principal Investigator
Washington University School of Medicine (ID-CRU)